510(k) · Cleared
ClearedAFX™ Femoral Implant With Inserter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cayenne Medical, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Aug 3, 2016 as substantially equivalent to K122463 (Cayenne Medical, Inc., 2012) after a 112-day review. Its family tree reaches back 2 generations to 2009. 1 later device descends from it.
- Decided
- Aug 3, 2016
- Review
- 112 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K083612 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK083612 Aperfix Femoral Implant with Inserter, 9,10,11 MM X 35MM and X 29MMCayenne Medical, Inc. · 2009 · Recalled
- 1 generation backK122463 Aperfix AM Femoral Implant with Inserter, 9X24 Aperfix AM Femoral…Cayenne Medical, Inc. · 2012
- This deviceK161033 AFX™ Femoral Implant With InserterCayenne Medical, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK192428 AFX Femoral Implant with InserterCayenne Medical · 2019
Most influential descendants
Showing 1 of 1 · See all- K192428AFX Femoral Implant with InserterCayenne Medical · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K083612 | Aperfix Femoral Implant with Inserter, 9,10,11 MM X 35MM and X 29MM | Cayenne Medical, Inc. | 2009 | 1 |
| −1 | K122463 | Aperfix AM Femoral Implant with Inserter, 9X24 Aperfix AM Femoral Implant with… | Cayenne Medical, Inc. | 2012 | — |
| 0 (this device) | K161033 | AFX™ Femoral Implant With Inserter | Cayenne Medical, Inc. | 2016 | — |
| +1 | K192428 | AFX Femoral Implant with Inserter | Cayenne Medical | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122463 | Aperfix AM Femoral Implant with Inserter, 9X24 Aperfix AM Femoral Implant with Inserter…Summary page 4…e (480) 502-3661 FAX (480) 502-3670 Smooth or threaded metallic bone fixation fastener AFX"™ Femoral Implant with Inserter AperFix® AM Femoral Implant with Inserter (K122463) FDA has classified bone fixation fasteners as Class Il devices (21 CFR 888.3040). The product code for Fastener, Fixation, Nond… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192428 | AFX Femoral Implant with Inserter | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 3.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K192428 (Cayenne Medical, 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The AFX Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts, utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161033: AFX™ Femoral Implant With Inserter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161033
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026